A Study to Evaluate Safety and PK of Multiple Doses of LT3001 Drug Product and Drug-drug Interaction in Healthy Subjects

NCT ID: NCT04809818

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-21
• Study Completion Date: 2021-08-05

Brief Summary

This Phase 1 study is planned to establish the clinical safety and pharmacokinetics profile of multiple dose of LT3001 drug product and to investigate drug interactions of LT3001 with potential concomitant medications in healthy subjects.

Detailed Description

This study is a two-part study. Part A is double-blind, placebo-controlled, and will examine the safety and PK profiles of multiple doses of LT3001 drug product in healthy subjects. Part B is open-label and will assess the safety and PK of LT3001 when coadministered with aspirin, clopidogrel, apixaban or dabigatran.

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Part A - LT3001 Drug Product

Multiple doses of LT3001 administered by intravenous infusion

Group Type: EXPERIMENTAL

LT3001 drug product

Intervention Type: DRUG

Multiple doses of LT3001 drug product administered by intravenous infusion

Part A - Placebo

Multiple doses of Placebo administered by intravenous infusion

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Multiple doses of Placebo administered by intravenous infusion

Part B - LT3001 and Aspirin

Multiple doses of LT3001 and Aspirin administered

Group Type: EXPERIMENTAL

LT3001 drug product

Intervention Type: DRUG

Multiple doses of LT3001 drug product administered by intravenous infusion

Aspirin

Intervention Type: DRUG

Loading and maintenance doses of Aspirin administered by oral

Part B - LT3001 and Clopidogrel

Multiple doses of LT3001 and Clopidogrel administered

Group Type: EXPERIMENTAL

LT3001 drug product

Intervention Type: DRUG

Multiple doses of LT3001 drug product administered by intravenous infusion

Clopidogrel

Intervention Type: DRUG

Loading and maintenance doses of Clopidogrel administered by oral

Part B - LT3001 and Apixaban

Multiple doses of LT3001 and Apixaban administered

Group Type: EXPERIMENTAL

LT3001 drug product

Intervention Type: DRUG

Multiple doses of LT3001 drug product administered by intravenous infusion

Apixaban

Intervention Type: DRUG

Multiple doses of Apixaban administered by oral

Part B - LT3001 and Dabigatran

Multiple doses of LT3001 and Dabigatran administered

Group Type: EXPERIMENTAL

LT3001 drug product

Intervention Type: DRUG

Multiple doses of LT3001 drug product administered by intravenous infusion

Dabigatran

Intervention Type: DRUG

Multiple doses of Dabigatran administered by oral

Interventions

LT3001 drug product

Multiple doses of LT3001 drug product administered by intravenous infusion

Intervention Type: DRUG

Placebo

Multiple doses of Placebo administered by intravenous infusion

Intervention Type: DRUG

Aspirin

Loading and maintenance doses of Aspirin administered by oral

Intervention Type: DRUG

Clopidogrel

Loading and maintenance doses of Clopidogrel administered by oral

Intervention Type: DRUG

Apixaban

Multiple doses of Apixaban administered by oral

Intervention Type: DRUG

Dabigatran

Multiple doses of Dabigatran administered by oral

Intervention Type: DRUG

Other Intervention Names

LT3001 injection; Placebo of LT3001 drug product; Aspirin tablet; Clopidogrel tablet; Eliquis®; Pradaxa®

Eligibility Criteria

Inclusion Criteria

• Subject's body weight is ≥50 kg and BMI is within the range of 18 to 32
• Subject is a healthy volunteer.
• Subject's PT, aPTT, and TT are within the normal laboratory range.
• Subject is a nonsmoker

Exclusion Criteria

• Subject has a current or recent history of regular alcohol consumption.
• Subjects who are enrolled in Part B and allergic to acetylsalicylic acid, other salicylates, clopidogrel, thienopyridines (eg, ticlopidine, prasugrel), apixaban or dabigatran.
• Part B Cohort 2 only: subjects who are poor metabolizers of clopidogrel (CYP2C19*2/*2, *2/*3, or *3/*3 genotype)
• Subject has a presence or history of coagulation abnormality.
• Subjects need to receive a surgery or clinical procedures associated with high bleeding risk.
• Subject has a history of minor bleeding episodes, eg, epistaxis, rectal bleeding, gingival bleeding.
• Subject has a history of peptic ulcer or gastrointestinal bleeding.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lumosa Therapeutics Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mimi Yeh, PhD

Role: STUDY_DIRECTOR

Lumosa Phase 1 unit

Locations

Lumosa Phase 1 Unit

Cypress, California, United States

Countries

United States

Other Identifiers

LT3001-105

Identifier Type: -

Identifier Source: org_study_id